Combination Artificial Airway Device and Esophageal Obturator

ABSTRACT

A combination artificial airway device and esophageal obturator ( 10 ) includes a pressure indicator ( 25 ) surrounding a pilot balloon ( 28 ) for continuous monitoring of the internal pressure within the cuffs ( 14  &amp;  16 ).

RELATED APPLICATIONS

This application is a divisional of application U.S. Ser. No. 11/368,881filed on Mar. 6, 2006 which is a continuation-in-part of U.S. Ser. No.10/289,655 filed on Nov. 7, 2002, now issued U.S. Pat. No. 7,040,322 B2which is a continuation-in-part of U.S. Provisional Application60/339,092 filed on Nov. 8, 2001.

TECHNICAL FIELD

The field of this invention relates to medical airway device having asupraglottic inflatable cuff and a cuff pressure indicator.

BACKGROUND OF THE DISCLOSURE

Endotracheal tubes have long been accepted to establish a direct pathfrom the trachea to the ambient exterior or to a ventilation machine.However, endotracheal intubation requires a high degree of skill and theuse of supporting medical devices such as a laryngoscope forvisualization of the glottis. Furthermore, an endotracheal tube on itsway to a trachea passes into the larynx and adjacent to delicatestructures which poses a potential for serious damage to this importantspeech organ. Accidental insertion into the esophagus can also occur.

Supraglottic masks which do not intrude into the trachea avoid the knownproblems of endotracheal tubes. Laryngeal masks, as a supraglotticdevice, have become accepted alternatives to avoid the need of sealingwithin the trachea or the accidental insertion of the endotracheal tubeinto the esophagus.

Early versions of alternatives to endotracheal tubes used inflatablecuffs but needed an exterior face mask placed over the face of thepatient to stop air leakage while the patient is being ventilated viathe air ports.

One widely accepted laryngeal mask device is disclosed in U.S. Pat. No.4,509,514 to Archibald Brain. This artificial airway device is in theform of a laryngeal mask airway. This laryngeal mask airway comprises ofa tube opening into the interior of a mask portion. The periphery of themask may be inflatable and provides a seal around the inlet of thelarynx.

A disadvantage related with the use of this traditional laryngeal maskdevice is encountered in patients who are at risk from vomiting orregurgitating stomach contents while unconscious. Although the device isknown to form a seal around the laryngeal inlet sufficient to permitartificial ventilation of the lungs, this seal may be sometimesinsufficient to prevent lung contamination during retching, vomiting orregurgitation. Besides, the bulk size of these devices may impede, orcreate difficulties to the prompt access to the esophagus for thepassage of an oral or nasal gastric tube to drain eventualesophageal/stomach contents. Due also to its design, it is possible thatwhen a certain ventilation pressure is reached or when the device is notproperly placed, a leak of gases from the repetitive ventilationattempts may reach and enter the esophagus, inflating the stomachincreasing the risk of regurgitation and discharge of its contents.

In order to minimize these serious problems, modifications were proposedand introduced on these laryngeal mask ventilation devices to provide asort of gastric drainage as disclosed in U.S. Pat. Nos. 5,241,956 and6,439,232 to Brain. These were all basically designed by adding a secondesophageal tube, ending at the supraglottic mask distal cuff tip. Thissecond tube is usually molded by a semi rigid open ring, inside the bodyof the pneumatic cuff of the mask. This construction, when all isworking well, allows the hollow orifice of the esophageal tube to beproperly aligned with the esophageal entrance, so it could drain itscontent or allow a passage of an oro-gastric tube through it.

However for this device to work, proper insertion and positioning of theventilation device (supraglottic mask) at the hypopharynx is critical.Its tip must be properly facing the esophageal entrance. If the mask isnot in the right position, the proposed esophageal draining may notproperly occur which may result in an increased risk of leakage of theesophageal/gastric contents. Any such contents may then be undesirablyaspirated into the lungs with serious consequences. In order toaccommodate an esophageal draining tube in addition to the trachealtube, the thickness of this device is increased. The increased thicknessmay make proper insertion and installation of the device into thepatient's throat more difficult.

Another device directed to reducing the risk of regurgitation and at thesame time to provide for lung ventilation is disclosed in U.S. Pat. No.5,499,625 by Frass. This is a twin lumen coaxial device designed for usein emergency situations and difficult airways. It can be insertedblindly into the oropharynx and usually enters the esophagus in about90% of times. It has a low volume inflatable distal cuff and a muchlarger proximal pharyngeal cuff designed to completely occlude theoropharynx and the nasopharynx. It provides effective lung ventilationregardless of whether esophageal or tracheal placement is accomplished.When it is placed in the trachea, it functions as an endotracheal tube,with the distal cuff sealing the tube against the tracheal wall. Whenits distal cuff is in the esophagus, ventilation is possible through asecond lumen that ends at perforations at the pharyngeal side of thetube above the lower cuff that occludes the esophagus and below theupper pharyngeal cuff. Due to its design, this device is limited tounconscious patients over five feet (5) in height. Furthermore, anoperator needs to be aware of symptoms to assure proper placement. Ifauscultation of breath sounds are negative and gastric insufflation ispositive, the operator needs to immediately switch the lumen to provideair into the alternate airway. Its positioning is critical, as theairway could be occluded if not properly placed and the proper lumen isnot used.

U.S. Pat. No. 4,995,388 to Archibald I. Brain discloses a larynx maskwith a drain tube intruding into the esophagus and with an esophagealsealing cuff. Proper insertion of this particular device is verydifficult. Also, in this device, the inflation line leads to the pharynxcuff and then serially down to the esophageal cuff.

U.S. Pat. Nos. 5,241,956; 5,355,879; 5,632,271; and 5,878,745 toArchibald Brain disclose a respective larynx mask with two inflatableseals for sealing about the pharynx. The seals may be inflated by acommon inflation line or by separate inflation lines.

U.S. Pat. No. 4,016,885 to Bruner issued on Apr. 12, 1997, has describeda device to indicate the gas pressure in inflatable cuff-type catheters,by expansion of the cuff and scaling this expansion. The main goal ofBruner's device is to provide a pressure indicator for endotracheal andtracheostomy tubes, to avoid trauma due to overpressure. This is mainlyachieved by employing an open ended spring wound at the mid-section ofan elliptically shaped expansion chamber. However, this device is notdesigned to measure and alert the occurrence of under pressure events.

What is needed is a supraglottic mask with an esophageal drain tube andesophageal cuff in combination with an improved seal on the pharynxcuff, an improved pressure indicator, and an improved method ofinstallation that will quickly form an esophageal obturator to reducerisk of choking on gastrointestinal contents.

SUMMARY OF THE DISCLOSURE

In accordance with one aspect of the invention, an inflatablesupraglottic mask for an artificial airway device has an inflatablesupraglottic cuff with an inflatable peripheral seal with walls. Eachwall has inner and outer surfaces in part defining the pressuredinterior of the peripheral seal. A plurality of tension supports extendbetween and are connected to both of the inner and outer surfaces andextend through the pressured interior of the peripheral seal to preventthe surfaces from lateral deformation outward when the cuff is inflated.For some applications, this supraglotical cuff could also be made plainwith soft walls, without creases, in a tire like fashion.

Preferably this supraglottic mask for an artificial airway deviceincludes an inflatable supraglottic cuff having a peripheral seal withbellow shaped walls for inflating to a wedge shape. On the bellow shapedsupraglotical cuff version, the bellow shaped walls have a plurality ofbellow creases that fan out from an interior apex section when inflatedto provide the inflated wedge shape from the interior apex section to aproximal wide section. The inflatable supraglottic cuff is connectableto air pressure lumen for control of inflation and deflation of thebellow shaped walls.

In accordance with another aspect of the invention, an inflatablesupraglottic mask for an artificial airway device has an inflatablesupraglottic cuff with an inflatable peripheral seal. The seal hasbellow shaped walls each having opposing pleated surfaces opposing eachother. A plurality of tension supports extend between and are connectedto both of the opposing pleated surfaces to prevent the pleated surfacesfrom deformation outward when the cuff is inflated.

Preferably, the plurality tension supports each are in the form of apocket with lateral walls extending from a lateral outer surface of thebellow shaped wall to a lateral inner surface of the bellow shaped wall.It is desired that the plurality of pockets are spaced about theperipheral seal of the cuff.

In accordance with another aspect of the invention, an inflatable cufffor an artificial airway device has an inflatable peripheral seal withbellow shaped walls for inflating to a wedge shape. Each bellow shapedwall has a plurality of opposing pleated surfaces. A plurality oftension supports extend across the interior of the inflatable peripheralseal and are secured to both of the opposing pleated surfaces.

Preferably the supraglottic mask has a conduit with two separatetracheal and esophageal lumens laterally positioned adjacent each otherwith the tracheal lumen having an inlet within the confines of theperipheral seal and the esophageal lumen extending through an esophageallimb posteriorily of the wedge in proximity to the apex section. It isdesired that the posterior wall of the conduit is substantially flat toreduce rotation while positioned in the pharynx section of a patient.

It is also desired that the double lumen conduit has a substantiallyrectangular cross-sectional configuration with rounded corners forreducing its thickness. The bulkiness in the oro-pharyngeal cavity andhypopharynx is thus reduced, which in turn reduces the chances oftrauma, although preserving its cross-sectional area to assure theproper flow of air to the trachea and for any eventual esophagealdrainage.

It is further desired that an epiglottis band is attached near the wideror proximal border of the supraglottic cuff at an anterior section ofthe bellows for lateral extension and facing a laryngeal aperture topush forward and protect an epiglottis up to its natural flexed andopened position during the pneumatic expansion of the supraglottic cuffthereby reducing the risk of trauma to the epiglottis.

In one embodiment, the conduit has a reinforced ring located at theproximal segment thereof just before the conduit separates into aventilation limb and esophageal limb for reducing damage and kinking ofthe double lumen tube when it passes through the mouth and teeth.

In accordance with another aspect of the invention, a combinationartificial airway device and esophageal obturator includes asupraglottic inflatable cuff for installation above the esophagealopening at the oropharynx and the hypopharynx, and an esophagealinflatable cuff for installation in the esophagus. A tracheal lumen hasan inlet within the peripheral seal formed by the supraglottic cuff. Anesophageal drain lumen extends past the supraglottic inflatable cuff andthrough the esophageal cuff. An inflation line is serially connected tothe esophageal cuff and then to the supraglottic cuff such that theinflating air supply passing through the inflation line passes to theesophageal cuff before passing to the supraglottic cuff.

The inflatable supraglottic cuff has an inflatable peripheral seal withwalls that have inner and outer surfaces in part defining the pressuredinterior of the peripheral seal. A plurality of tension supports extendbetween and are connected to both the inner and outer surfaces andextend through the pressured interior of the peripheral seal to preventthe surfaces from lateral deformation outward when the cuff is inflated.

Preferably, the inner and outer walls have a bellow shaped with pleatsfor inflating to a wedge shape. The pleats fan out from a interior apexsection when inflated to provide the inflated wedge shape from theinterior apex section to a proximal wide section. The tension supportsextend between and are connected to opposing pleats to prevent thepleats from blowing out to retain the bellow shape when the supraglotticinflatable cuff is inflated.

It is preferred that a section of the inflation line passing from theesophageal cuff to the supraglottic cuff has more restriction than theinflation line leading to the esophageal cuff thereby promotinginflation of the esophageal cuff before inflation of the supraglotticcuff during normal inflation rates, such that the esophagus is isolatedand previously sealed by the inflated esophageal cuff before thesupraglottic cuff assumes its final inflated and sealing position.

It is further desired that the supraglottic cuff has its peripheral sealformed from bellow shaped walls for inflating to a wedge shape. Thebellow shaped walls have a plurality of pleats or folds that fan outfrom an interior apex section when inflated to provide the inflatedwedge shape from the interior apex section to a proximal wide section.

In another aspect of the invention it is desired that the supraglotticcuff could also have its peripheral seal formed from plain shaped wallsfor inflating to a wedge shape. The cuff walls expands out from aninterior apex section when inflated to provide the inflated wedge shapefrom the interior apex section to a proximal wide section.

In accordance with another aspect of the invention, a combinationartificial airway device and esophageal obturator includes asupraglottic inflatable cuff for installation above the esophagealsphincter or opening at the oropharynx and hypopharynx, and anesophageal inflatable cuff for installation in the esophagus. A tracheallumen has an inlet entrance within the confines of the supraglottic cuffand in communication with the tracheal passage of the patient.

An esophageal lumen extends past the supraglottic inflatable cuff andthrough the esophageal cuff. An inflation line is for inflating both theesophageal cuff and supraglottic cuff. The supraglottic cuff has anasymmetrical inflatable section that has a wider proximal sectionsituated above the epiglottis with its distal thinner termination endsituated over the esophageal sphincter or entrance just behind thelarynx to provide increased stability by its two points of sustainfixation. The stability is assured by a firmly positioned terminalesophageal cuff inside the esophagus, and the second, or the proximalpoint, at the exterior segment of the asymmetrical supraglottic cuffsecured in the oropharynx area and fixed externally to the peri-oralaperture. This stable two point security makes it possible, duringpneumatic expansion, to ergonomically embrace and seal theperi-laryngeal structures contour.

Preferably, the tracheal lumen and esophageal lumen are in a low profiledouble lumen tube with the lumens asymmetrically positioned laterallyside by side. Preferably the tracheal lumen is wider than the esophageallumen. The tube has a substantially flat posterior wall. The posteriorwall in one embodiment is directly abuttable with the posterior wall ofthe pharynx and hypopharynx thereby restraining the tubes rotation whileproviding a solid and also stable base for the supraglottic cuffexpansion.

Preferably, the supraglottic inflatable cuff is designed to be inflatedin sequence after the esophageal cuff is pressurized by an independentbackward fed internal inflation-deflation tube originating from theesophageal cuff and draining to the supraglottic cuff.

It is also desired that the device has a slight “s” shape form with adownward inclination of its distal point to facilitate esophageal accessand an upward inclination of approximately 70 degrees angle proximal tothe supraglottic cuff to be compatible with the anatomy of the pharynxtoward the mouth.

It is preferred that a pilot balloon is mounted in the inflation line.The balloon is made from an elastic material and is circumferentiallysurrounded by a semi-spiral cylinder made from a resilient springmaterial. As a result of the pilot balloon inflation, the spring expandsand is calibrated to indicate the pressure in the inflation line andcuffs. The expansion of the pilot balloon is a result of its inflation.The pressure build up will force an increase in the semi-spiral cylinderdiameter that can be calibrated in a scale reflecting the internalpressure in the inflation line and cuffs.

In accordance with another aspect of the invention, a cylindrical pilotballoon is inserted in an inflation line leading to the sealing cuff. Asemi-spiral cylinder extends the entire length of and circumscribes,i.e., circumferentially surrounds the pilot balloon. The semi-spiralcylinder is made from a resilient spring like material. Its expansion isa result of expansion of the pilot balloon and is visually marked toindicate an acceptable pressure range in the inflation line. Thesemi-spiral cylinder has an increase in diameter and its free edge,acting as an indicator, sliding over another wall section of thesemi-spiral cylinder which has a color scale thereon for continuouslyindicating the pressure status in the sealing cuff and to visually alertwhen a pressure outside the acceptable pressure range occurs. Othereasily readable scales are also foreseen.

Preferably, the color scale for continuously indicating the pressure inthe sealing cuff has a green bar which when revealed by the sliding freeedge, indicates that the internal cuff pressure is within the normallimits and at least one red bar for indicating an abnormal pressurecondition. Desirably, the green bar is placed between two red bars.

In accordance with another aspect of the invention, a method ofintubation of a patient includes inserting an artificial airway deviceand esophageal obturator through the mouth and pharynx of a patient andinserting its distal end into the esophagus of the patient such that anesophageal drain tube and esophageal cuff are positioned in theesophagus and a supraglottic cuff with a tracheal lumen is positionedabove the esophageal entrance with the tracheal lumen in communicationwith the trachea of the patient. The method further includes inflatingthe esophageal cuff to seal off the esophagus and subsequently inflatingthe supraglottic cuff to provide a seal about the peri-laryngealstructures of the patient.

It is preferred that the method includes the supraglottic cuff beingasymmetrically shaped such that when inflated, its proximal section iswider and positioned above the epiglottis and a narrow section is placedat the opening of the esophagus.

It is preferred that the epiglottis of the patient is retained in itsnormal open up position toward the anterior wall of the pharynx by astrap laterally extending across the supraglottic cuff between twoinflatable side walls of the cuff.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference now is made to the accompanying drawings in which:

FIG. 1 is a perspective view of a larynx mask ventilation device;

FIG. 2 is an enlarged fraymentary view illustrating the esophageal andsupraglottic cuffs;

FIG. 3 is a front elevational view of the cuffs shown in FIG. 2;

FIG. 4 is a rear elevational view of the cuffs as shown in FIG. 2;

FIG. 5 is a front perspective of the supraglottic cuff;

FIG. 6 is a cross-sectional view taken along lines 6-6 shown in FIG. 2;

FIG. 6A is a view similar to FIG. 6 showing a pleatless modifiedembodiment;

FIG. 7 is a view similar to FIG. 6 illustrating a modified embodiment;

FIG. 7A is a view similar to FIG. 7 showing a pleatless modifiedembodiment;

FIG. 8 is a cross-sectional view of one wall of the supraglottic cufftaken along lines 8-8 shown in FIG. 5;

FIG. 9 is a cross sectional view taken along lines 9-9 shown in FIG. 2;

FIG. 10 is a schematic view illustrating the serial air path forsequentially inflating and deflating the esophageal and supraglotticcuffs;

FIG. 11 is a diagrammatic and generally side elevational view shown inan initial position in a patient with both cuffs deflated;

FIG. 12 is a view similar to FIG. 11 illustrating the esophageal cuffinflated in position;

FIG. 13 is a view similar to FIG. 11 illustrating the device in a fullyinstalled position with both the esophageal and supraglottic cuffsinflated;

FIG. 14 is a enlarged fragmentary and exploded view of the pilot balloonshown in FIG. 1; and

FIG. 15 is a cross-sectional view taken along lines 15-15 shown in FIG.1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIG. 1, a combination artificial airway device andesophageal obturator 10 includes a laryngeal mask 12 that has aninflatable supraglottic cuff 14. The device 10 also includes aninflatable esophageal cuff 16 near a distal end of an esophageal draintube 18.

The device 10 is shown in a resting position with a “S” like shape withthe distal end of the drain tube 18 curved in a convex or uprightdirection as shown in FIGS. 11-13 and the conduit 20 curvedapproximately at an angle of 70 degrees in an opposite or concavedirection, i.e. downward direction as shown in use in FIGS. 11-13. Ofcourse, the device is flexible to allow proper handling andinstallation.

The proximal end of conduit splits off into an esophageal limb 22,tracheal limb 24 and inflation limb or tube 26 with pilot balloon 28.The pilot balloon 28 can be made from an elastic material and isgenerally cylindrical in shape. As shown more clearly in FIGS. 14 and15, the pilot balloon 28 is circumscribed or circumferentiallysurrounded along its entire length by a semi-spiral cylinder 25 madefrom a resilient spring like material (thin metal or plastic) where itsexpansion, in consequence of the pilot balloon inflation, can bevisualized and calibrated to indicate the internal pressure. It alsowill recoil, i.e., resiliently return to a normal rest position whichcorresponds to a deflated position of the pilot balloon. The expansionof this pilot balloon, as a result of its inflation and a pressure buildup, will force an increase in the semi spiral cylinder diameter that canbe calibrated through a scale 27. The scale 27 may be an easily readtext scale or a color scale, for example red colored bars 29 and 33 forover pressure or under pressure and green colored bar 31 interposedbetween the two red bars 29 and 33 corresponding to a correct inflationpressure. The colored bars 31, 33 and 37 may extend substantially theentire length of the semi-spiral cylinder 25. The distal edge 23 of thespiral spring 25 lies over the under layer with the red colored bars 33and 37 and green colored bar 31 thereon. By this way, monitoring andindicating of main cuff internal pressure is continuous during alltimes, reflecting its immediate inflation and deflation status. Thepilot balloon 28 with the bars 31, 33, and 37 can then be used as anindicator of the proper inflation pressure inside the two main cuffs 14and 16.

A reinforcing ring 30 is placed about conduit 20 just before thesplitting off of limbs 22, 24 and 26. The proximal ends of limbs 22, 24,and 26 may have standard connectors well known in the art. Limb 24 mayhave for example a 15 mm male connector. Limb 26 may have for example aunidirectional valve and a syringe adaptor.

Referring now to FIGS. 2-4, the conduit 20 is a double lumen tube with atracheal lumen 32, esophageal lumen 34 and inflation line 29 therein.Inflation line 29 is fluidly connected to inflation limb 26. Line 29 canbe approximately 1 mm plastic tube for inflating and deflating the cuffs14 and 16. The lumens 32 and 34 are laterally positioned from each otherwith a common dividing wall 35 therebetween. The conduit 20 has aflattened shape with relatively flat anterior wall 36 and posterior wall38. Conduit 20 has a generally rectangular cross-section shape withrounded corners.

The mask 12 includes the supraglottic cuff 14 which provides aperipheral seal 15 that is substantially tear drop shaped or oval shapedabout a concave front side with a center recess 40 that has an entrance42 to the tracheal lumen 32. An epiglottic band 50 laterally extendsacross recess 40 and is attached to the two side walls 44 of the cuff inproximity to the proximal upper wall 48. The two side walls 44 merge ata distal apex 46 section.

The apex section 46 of the supraglottic cuff is spaced from esophageallumen 16 and connected thereby with an intermediate section 52 ofconduit 20. This section 52 has lumen 34 therein along with inflationline 29 extending directly to esophageal cuff 16 and a restrictive line54 that extends from the esophageal cuff 16 to the supraglottic cuff 14.The line 54 is significantly more restrictive than line 29 by having asubstantially smaller diameter as clearly shown in FIG. 9. Intermediateline 54 connects directly to and forms part of the esophageal drain tube18.

Esophageal cuff 16 is an annular inflatable bladder that inflates withair pressure introduced from line 29. The conduit line 54 of the draintube 18 passes therethrough and is sufficiently rigid to not collapseunder normal operating cuff pressures exerted on esophageal cuff 16. Thedistal end 55 of line 18 has a rounded duck bill shape, i.e. taperedshape, with drain opening 56 therein.

Air pressure can pass into line 54 to fill up supraglottic cuff 14.Conduit 20 is similarly sufficiently rigid to withstand collapse fromnormal inflation pressures exerted by inflated cuff 14.

As shown more clearly in FIG. 6, the side walls 44 are formed by bellowsor pleats 60 which give the walls 44 an accordion like or pleatedappearance. Proximal upper wall 48, not shown in FIG. 6, is similarlyconstructed. The bellows or pleats 60 merge near the apex 46 to providemore expansion or inflation near the proximal upper wall 48 to provide awedge shape for the cuff 14 when inflated. A portion 61 of side wall 44is integral with side walls 62 of conduit 20. Side walls 44 and proximalupper wall 48 are inflatable and thus expandable such that it forms adefined recess 40 on its concave side in front of the anterior wall 36of conduit 20. The normal position of the bellows 60 may be in thedeflated state as shown in FIGS. 1 and 11. The pleats may provide someresilient bias to the deflated position which is shown in FIGS. 11 and12 from the inflated state shown in FIG. 13.

Alternatively as shown in FIGS. 6A and 7A, the same supraglottic cuff 14may have the walls 44 plain, i.e. have a pleatless columnar shape. FIG.7A refers to the same design were supraglottic cuff 14 extend to aposterior inflatable section 64 that is situated posteriorly of wall 38.

The conduit 30 has a substantially rectangular cross-sectionalconfiguration with rounded corners. The posterior wall 38 is thussubstantially flat in a lateral direction and forms a posterior wallthat is abuttable against the posterior wall of the hypopharynx of thepatient as shown in FIGS. 11-13.

Alternatively as shown in FIG. 7, a supraglottic cuff 14 may have thewalls 44 extend to a posterior inflatable section 64 that is situatedposteriorly of wall 38. In this embodiment, the posterior section has aposterior wall 66 that is spaced from wall 38 and is shaped to abutagainst the posterior walls of the hypopharynx section of the patient.

The walls 44 and 48 have radially inner and outer surfaces 45 and 47 asclearly shown in FIGS. 5-8. The pleats 60 on each surface 45 and 47oppose each other. Tensioning straps or other supports 51 extend fromopposing pleats 60 on the respective surfaces 45 and 47 across theinterior 53 of the cuff 14 and become taut when the cuff is inflated toprevent the pleats 60 from flexing outward. Thus, the pleats 60 and cuff14 are more stable against laterally directed stresses that mayotherwise blow out the pleats 60 when the cuff is in the expandedinflated state.

These tensioning straps 51 may be spaced about cuff 14 and on each setof opposing pleats 60. Due to manufacturing expediencies, the straps 51may be formed by molding about a punch so that a pocket 57 is formedthat extends all the way from the outer surface 47 to the inner surface45. The straps 51 thus can have side walls 58 and top and bottom walls59. Thus, the spaced straps 51 with the pockets 57 have an asymmetricallook to them from the outer surface 47 to the connection with innersurface 45 as shown in FIGS. 5, 6 and 8.

While the illustrated straps 51 and pockets appear to be flattenedrectangular shapes, trapezoidal or tubular straps are also foreseen.Wedge shaped pockets 57 are also foreseen. Symmetrical straps formed bypockets extending from both surfaces 47 and 45 are also foreseen thatare fused together along a center line of the walls 44 and 48. FIG. 7shows an alternate strap 51 which is a single layer of elastomericmaterial extending between the pleats 60 with no formed pocket 57.

In operation, the device 10 is manually inserted through the mouth 68 ofa patient as shown in FIG. 9 in a deflated condition. The distal end isdirected through the esophageal sphincter 72 and into esophagus 70. Therounded duck bill end 55 of the drain tube section 18 and the “S” shapeof the device promote entry into the esophagus 70. The rounded duck billend 55 reduces trauma when it breaches through the esophageal sphincter.

The positioning of the device is easy because resistance is felt whenthe mask 14 apex portion 46 is lowered behind the arytenoid cartilage onthe posterior wall of the supraglottic larynx. More particularly apex 46is nested at the esophageal sphincter. Further insertion is thenresisted which can be easily felt by the nurse, doctor or the operator.This increased resistance signals when to stop insertion and begininflation through limb 26.

In this intruded position, the reinforced ring 30 is aligned with theteeth 69 within mouth 68 such that any pressure to close the conduit 20and any of the lumens 32, 34 and inflation line 29 is successfullyresisted by the structural support of the ring 30. It is also foreseenthat the conduit material itself may be reinforced in this area to bestructurally resistance against collapse.

As inflation proceeds through limb 26 the esophageal cuff 16 is thefirst cuff to inflate because line 29 proceeds directly to cuff 16. Inother words line 29 bypasses cuff 14 and proceeds directly to cuff 16.The inflation of cuff 14 is also delayed because the line 54 thatcommunicates from cuff 16 back to cuff 14 is restrictive which delaysthe inflation of cuff 14. The line 54 is small enough to delay theinflation of cuff 14 until cuff 16 if fully inflated during normalinflation rates for such devices 10. A schematic of the inflation linesis shown in FIG. 10 which schematically shows pilot 28, limb 26, line29, esophageal cuff 14, restrictive line 54 and supraglottic cuff 14serially connected.

It is also foreseen that other mechanism can be used to sequence theinflation of the cuffs 16 and 14 in the desired order. The material ofcuff 16 may be more flexible and be slowed to inflate under lesspressures than the materials used in cuff 14. Another alternative isthat the pleats 60 may provide enough resilient resistance toward thedeflated position against the inflation until the cuff 16 is fullyinflated. The main point is that the device provides for a sequencedinflation of esophageal cuff 16 before the inflation of the cuff 14.

The advantage for the inflation of the esophageal cuff 16 is thatsequencing the inflation of the two cuffs provides for a fasterinflation of the esophageal cuff 16 which provides faster protectionagainst any potential regurgitation by the patient.

FIG. 12 shows the intermediate step when the esophageal cuff 16 is fullyinflated but the cuff 14 is still in the deflated position. As shown asthe cuff 16 is fully inflated, air is still passed through limb 26 andline 29 and now it flows through cuff 16 and back through line 54 tosupraglottic cuff 16.

Referring now to FIG. 13, the cuff 16 inflates, the cuff or bellowsexpand to provide for the side walls 44 and proximal wall 48 to increasewidth and form a seal about the tracheal entrance 74. The trachealentrance 74 is sealed from the esophageal passage. The tracheal entranceis in communication with tracheal entrance 42 in the recess of the mask12. The walls 44, 48 and apex 46 provide for a complete seal byinflation which presses against the posterior wall 78 of the pharynxsuch that the inflated walls push against the anterior tissues 80 aboutthe laryngeal entrance 74.

The pleats 60 provide for an inflated cuff that is asymmetrical inshape. Namely, a wedge or cone type shape is accomplished with the apex46 near a narrow or thinner end and the wall 48 at the wider or thickerend. This wedge shape corresponds more closely with the natural shape ofthe patient's oro-pharynx and hypopharynx cavity. The tension straps 51provide for a more columnar format and deter the cuff sidewalls 44 and48 from distorting or expanding laterally or to assume a roundedtire-like shape.

The laryngeal entrance is in communication with the concave side orrecess 40 and the tracheal lumen entrance 42 which lead out to thetracheal limb 24.

The epiglottic band 50 is positioned and fixed on the side walls 44 tocatch up with the epiglottis 82 and while the cuff 14 is inflating theband will push the epiglottis forward to its naturally open or flexedposition as shown in FIG. 11. This reduces trauma to the epiglottis 82and reduces complications in lung ventilation.

As can now be recognized, any gastric or esophageal reflux can then bedrained through the tube 18 and lumen 34 out through limb 22. Ifnecessary, an oro-gastric tube can be easily passed directly to thestomach through the esophageal limb 22, lumen 34 and entrance 56.

After the device is used and removal is desired, the line 29 can beopened or a syringe can be used to deflate the two cuffs 14 and 16. Thecuff 16 will deflate first and then the cuff 14 will deflate to allowquick removal from the esophagus.

In this fashion the supraglottic cuff 14 will pneumatically inflate andexpand to seal the peri-laryngeal structures only after the esophagus isisolated and has been previously sealed by the inflated esophageal cuff16. This assures the esophageal limb 22 a free pathway of anygastric-esophageal content to the exterior. Furthermore, a separateperipheral seal is formed about the peri-laryngeal mucosa adding anextra guarantee against any aspiration of gastro-esophageal contents.This seal also provides a clear way for the ventilation of the lungs.

The two cuffs, with a flat non-rotatable conduit provides for a stableintubation device less prone to undesirable displacement. The flatrectangular shaped conduit with the side by side double lumen structurepositioned between the side inflatable walls 44 provide for a lowprofile mask 12 which can be easily inserted and then inflated to renderproper sealing.

Furthermore, the asymmetrical ergonomic wedge or cone like shape of theinflated supraglottic mask provides for less intrusion and trauma to thesurrounding tissues with the apex situated over the esophageal entranceor sphincter just behind the larynx and its wide end situated above theepiglottis. The band also provides for reduced trauma to the epiglottis.

The wedge like or cone like shape of the cuff allows the esophageallumen to pass behind the mask 12 while still maintaining a low profilefor easier insertion through the oral cavity and its passage throughoutthe oro-pharynx, hypo-pharynx and finally into the esophagus withreduced trauma of these structures.

The device may be made from an elastomeric silicone rubber or fromanother bio-compatible plastics in either a non-disposable and reusableformat or in a disposable format.

The optional rear inflation section can provide even further pressure onthe anterior wall of the hypo-pharynx to create increased forwardpressure against the peri-laryngeal supraglottic structures and creatinga tighter seal of the laryngeal entrance.

It is also foreseen that the tension straps can be incorporated intocolumnar walls that do not have pleats where the walls are taller thanthe separation of the two side surfaces 46 and 48. Even roundedtire-like walls of other supraglottic masks can incorporate thesetension straps to increase the lateral support of the walls and decreaseundesired lateral deformation.

The reinforced ring provides for reduced damage and reduced risk ofkinking of the double lumen conduit 20 when it passes through the mouthand teeth.

The continuous pressure monitor reduces the chance of overpressure andan over expansion of the cuffs which in turn may cause deleteriouseffects on the circulation (an increase in compression blocks or delaysthe mucosal circulation). This increased intracuff pressure could leadto a higher incidence of sore throat pain or even necrosis, from theeventual ischemia and injury. Another reason to monitor the intracuffpressure besides to avoid its initial “overinflation” is, also when aventilation device is used in anesthesia, and N₂O (Nitrous Oxide) gas isadded to oxygen (a common procedure to increase analgesia and reduceanesthetic consumption) this gas in time diffuses through the cuff wallsto inside the cuff, it will also in time increase the intercuffpressure.

Furthermore, an underpressure due to inappropriate cuff inflation couldalso be deleterious as the proper contact between the cuff walls and themucosal surface may not occur. This could lead to leaks of air duringthe patient ventilation, resulting in not only inappropriateventilation, but also an increased risk for lung aspiration of anyeventual gastric content, in case of regurgitation, as the properlaryngeal seal is not achieved. The continuous monitoring by the pilotballoon provides an extra safeguard against these undesirable traumas.

Variations and modifications are possible without departing from thescope and spirit of the present invention as defined by the appendedclaims.

1. A cuff pressure indicator for an artificial airway device having asealing cuff, said cuff pressure indicator comprising: a cylindricalpilot balloon inserted in an inflation line leading to said sealingcuff; a semi-spiral cylinder extending the entire length of andcircumferentially surrounding said cylindrical pilot balloon; saidsemi-spiral cylinder being made from a yieldably resilient spring likematerial where its expansion is caused by expansion of the pilotballoon, said semi-spiral cylinder being visually marked with visualindicia to indicate an acceptable pressure range in the inflation line;and said semi-spiral cylinder having an increase in diameter and adistal edge sliding over another wall section of said semi-spiralcylinder which has said visual indicia thereon for continuouslyindicating the pressure in said sealing cuff and to visually alert whena pressure outside said acceptable pressure range occurs.
 2. A cuffpressure indicator for an artificial airway as defined in claim 1further comprising: said visual indicia being a color scale thereon forcontinuously indicating the pressure in said sealing cuff, said colorscale comprising a green bar for indicating that the internal cuffpressure is within the normal limits; and at least one red bar forindicating an abnormal pressure condition.
 3. A cuff pressure indicatorfor an artificial airway as defined in claim 2 further comprising: saidgreen bar placed between two red bars; an indicator being the distaledge of a semi-spiral cylinder, sliding over another wall section of thesame cylinder; said semi-spiral cylinder increasing and decreasing inits diameter as a function of the expansion or contraction of saidcylindrical pilot balloon; and said cylinder shaped pilot balloonexpanding and contracting as a function of its internal pressurecorresponding to the relative cuff pressure.
 4. A cuff pressureindicator for an artificial airway device having a sealing cuff, saidcuff pressure indicator comprising: a cylindrical pilot balloon insertedin an inflation line leading to said sealing cuff; a semi-spiralcylinder extending along a length of and circumferentially surroundingsaid cylindrical pilot balloon; said semi-spiral cylinder being madefrom a yieldably resilient spring like material where its expansion iscaused by expansion of the pilot balloon; said semi-spiral cylinderhaving a distal edge sliding over an inner coil wall section of saidsemi-spiral cylinder which has visual indicia thereon for continuouslyindicating the pressure in said sealing cuff and to indicate anacceptable pressure range in the inflation line.
 5. A cuff pressureindicator for an artificial airway as defined in claim 4 furthercomprising: said visual indicia being a color scale thereon forcontinuously indicating the pressure in said sealing cuff, said colorscale comprising a green bar for indicating that the internal cuffpressure is within the normal limits; and at least one red bar forindicating an abnormal pressure condition.
 6. A cuff pressure indicatorfor an artificial airway as defined in claim 5 further comprising: saidgreen bar placed between two red bars; an indicator being defined by thedistal edge of a semi-spiral cylinder, sliding over said inner coil wallsection of the same cylinder to lie over said green bar when a correctcuff pressure is present and to lie over one of said two red bars whensaid cuff pressure is either too low or too high; said semi-spiralcylinder increasing and decreasing in its diameter as a function of theexpansion or contraction of said cylindrical pilot balloon; and saidcylinder shaped pilot balloon expanding and contracting as a function ofits internal pressure corresponding to the relative cuff pressure.
 7. Acuff pressure indicator for an artificial airway device having a sealingcuff, said cuff pressure indicator comprising: a cylindrical pilotballoon inserted in an inflation line leading to said sealing cuff; asemi-spiral cylinder extending the entire length of andcircumferentially surrounding said cylindrical pilot balloon; saidsemi-spiral cylinder being made from a yieldably resilient spring likematerial where its expansion is caused by expansion of the pilotballoon; and said semi-spiral cylinder having an increase in diameterand a distal edge sliding over another wall section of said semi-spiralcylinder which has a colored scale thereon for continuously indicatingthe pressure in said sealing cuff and to visually alert when a pressureoutside said acceptable pressure range occurs.
 8. A cuff pressureindicator for an artificial airway as defined in claim 7 furthercomprising: said color scale thereon for continuously indicating thepressure in said sealing cuff comprising a green bar for indicating thatthe internal cuff pressure is within the normal limits; and at least onered bar for indicating an abnormal pressure condition.
 9. A cuffpressure indicator for an artificial airway as defined in claim 8further comprising: said green bar placed between two red bars; anindicator defined by the distal edge of a semi-spiral cylinder slidingover another wall section of the same cylinder; said semi-spiralcylinder increasing and decreasing in its diameter as a function of theexpansion or contraction of said cylindrical pilot balloon; and saidcylinder shaped pilot balloon expanding and contracting as a function ofits internal pressure corresponding to the relative cuff pressure.